- Company Name
- Mentis Systems
- Job Title
- Program Manager
- Job Description
-
Job Title: Program Manager
Role Summary:
Lead and manage multiple regulated software and clinical application projects within a highly government‑regulated healthcare/medical device environment. Ensure compliance with FDA 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485, and manage end‑to‑end SDLC using Agile practices.
Expectations:
- Navigate complex regulatory frameworks and drive operational objectives.
- Facilitate cross‑functional collaboration, manage conflict, and prioritize in fast‑paced settings.
- Deliver integrated solutions on schedule and within budget while maintaining quality and compliance.
Key Responsibilities:
- Oversee end‑to‑end SDLC for regulated software products.
- Engage stakeholders to validate tools and ensure regulatory compliance.
- Plan, schedule, track, and forecast project budgets, resources, and risks.
- Facilitate Agile ceremonies, monitor Scrum metrics, enforce stage‑gate processes.
- Coordinate cross‑functional teams (engineering, quality, regulatory, clinical).
- Resolve impediments, manage conflict, and maintain stakeholder alignment.
- Mentor and develop team members; set priorities in a fast‑changing environment.
- Draft program documentation, presentations, and status reports.
- Promote consistency of departmental Agile practices and knowledge transfer.
Required Skills:
- 6+ years in a government‑regulated healthcare/medical device environment.
- Deep knowledge of FDA 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485, and stage‑gate processes.
- Strong leadership, stakeholder management, and conflict resolution.
- Proven experience with Agile/Scrum, Jira, and Confluence.
- Project budgeting, risk management, and resource planning.
- Excellent written, verbal, and presentation skills.
- Ability to manage matrixed resources and prioritize tasks.
Required Education & Certifications:
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
- PMP certification preferred.
- Scrum Master/CSM certification preferred.